MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number	INT30012UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An integrity bare metal stent was intended to be used to treat a lesion in the ostial, proximal rca which was mildly tortuous and mildly calcified.There were no abnormalities reported in relation to the anatomy.No damage was noted to the packaging.No issues were noted when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.Excessive force was not used.It was reported that the device failed to cross the lesion as it was unable to pass through another bms.When the physician attempted to pull back the device, resistance was met.The physician then pulled the delivery system back and was able to remove the device from the patient.Upon inspection post-removal, the stent struts appeared to be bent backwards and the stent appeared to be slightly displaced.The patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the stent was not positioned on the balloon between the marker bands as per specifications, stent had appeared to move distally.Crimp impressions were visible on the exposed balloon surface.No deformation was evident to the stent wraps.No deformation was evident to the distal tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7302974
• Report Number: 9612164-2018-00424
• Device Sequence Number: 11236091
• Product Code: MAF
• UDI-Device Identifier: 00613994798480
• UDI-Public: 00613994798480
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: INT30012UX
• Device Lot Number: 0007994745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 88